Federal control substance act Flashcards
Who should register with the DEA?
Manufacturers if they make CS or compounding pharmacies that deal with CS.
Distributors (wholesalers)
Dispensers (Pharmacies)
What is a form 223a?
It is a form to request reprints of lost DEA licenses
What is the form usually hung up on the wall in pharmacies?
form 223
What is a form 224?
It is to apply for a DEA license for pharmacies and you can use it to renew
What is a form 225?
It is a DEA license registration form for manufacturers or researchers. This could include pharmacists, just not in the dispensing role.
What is a form 363?
It is a DEA license registration form for narcotic treatment programs
When do DEA licenses expire?
36 months after last renewal.
It expires on the last day of the month
Can you do anything with an expired DEA license?
No
How long is the late license renewal for a DEA license?
30 days. After that, a new application must be completed
If you are moving, when should the DEA approve of the change of address?
PRIOR to the move.
A new DEA license will be issued. Both old and new licenses must be kept until a completed renewal cycle.
What do you do with your DEA license when it is expired?
Return the DEA license and any form 222s left.
When should you notify the DEA if you are transferring business?
Registrant must notify the DEA at least 14 days in advance
What should be documented in a transfer of business?
Registrant notifies Special agent in charge.
Name, address, registration number, and auth business activity of BOTH transferor and transferee.
Current address or other.
Date controlled substances will be transferred.
If C2s are involved, completed DEA 222s must be filed for EACH med transferred
When is DEA registration not needed?
Warehouses as long as it’s only used for storage.
Practitioner’s office (if drugs are not stored there)
Common carriers
What requires separate DEA registration?
Manufacturing CS
Distributing CS
Dispensing CII-IV
Research with CI-V
Narcotic treatment program for CII-V
Importing and exporting CS
Conducting chemical analysis of CS
What officials are exempt from getting a DEA license?
1) Military physicians (they use service ID and branch)
2) Physicians in training
3) Law enforcement
4) End user
5) During times of crisis or emergency
Is registration with DEA required for Scheduled listed chemical products (SLCPs)?
No, BUT they must self-certify that they meet the requirements with the feds to sell these
What must a pharmacy do if they want to sell bulk quantities of SLCPs?
They must register as a chemical distributor
Who schedules medications?
The DEA
What may a state do to the level of a schedule?
They may INCREASE the level. but they can not decrease it.
What are schedule I drugs?
High potential for abuse.
No current accepted medical use.
Lack safety data.
What are the noted schedule I drugs?
GHB
Heroin
Lysergic acid diethylamide (LSD)
Mescaline (Peyote)
Marijuana (Pot)
Methaqualone (Quaaludes)
Methcathinone
What are schedule II drugs?
Have a high potential for abuse.
Have an accepted medical use.
Abuse may lead to severe physical or psychological dependence.
What are the noted schedule II drugs?
1) Opiates or opioids (Codeine, HC, Methadone, Oxy)
2) Stimulants (Amphetamine, cocaine)
3) Depressants (Pentobarbital, Secobarbital)
4) Hallucinogens (Phencyclidine-PCP)
What are schedule III drugs?
Have a potential for abuse less than CI or CII.
Have a medical use.
Abuse may lead to moderate or low physical dependence or high psych depensdence.
What are the noted schedule III drugs?
1) APAP w/ codeine
2) Anabolic steroids
3) Buprenorphine
4) Butalbital w/ ASA
What are the schedule IV drugs?
Have low potential for abuse compared to CIII.
Current medical use.
What are the noted schedule IV drugs?
1) Alprazolam, Flurazapam, Clonazepam, Diazepam
2) Eszopiclone
4) Tramadol
What are the schedule V drugs?
1) Diphenoxylate/atropine (Lomotil)
2) 200 mg codeine per 100 ml
3) Pregabalin
4) Promethazine w/ codeine
What are examples of SLCPs?
Any product that contains ephedrine, pseudoephedrine, and phenylpropanolamine
Who decides which medication should be scheduled?
UN convention of psychotropic substances passes rule.
Secretary of health and human services.
Attorney general decides approval.
What factors are considered for substances to be scheduled?
Actual potential for abuse.
Scientific evidence of its pharmacological effect
Current scientific knowledge
History or pattern of abuse
Scope, duration, and significance
Psychic or physiological dependence
Is it already controlled?
How long is an emergency scheduling?
It’s good for one year.
If under investigation, extension for 6 months.
Attorney general can limit to schedule I only.
What form do you need to purchase or transfer a CI or CII?
DEA 222
Who can obtain a DEA 222?
Only CI or CII registered people
What is required to reorder more DEA 222 forms?
DEA 222a
Should be filled out by anything that cannot be altered.
The DEA 222 should be ____ prior to sending it to the seller.
Copied
How many DEA forms should be completed?
One by the purchaser and one by the seller.
The seller must send the completed DEA 222 forms of both parties within 30 days if it it not reported to ARCOS.
Who may fill 222 orders?
Manufacturer or distributor
Pharmacist at a CLOSING pharmacy
Registration is expiring without renewal
Registrant returning a CI or CII to the person they ordered from
Chemical analysis
Compounder of a narcotic treatment program
How soon must an order be completed for a 222?
within 60 days.
Where should lost 222 forms be reported to?
field office (DEA office)
How should 222 forms be stored?
Separate from other information.
Maintain for at least 2 years
Can a doctor self-prescribe?
Yes as long as it is in the usual course of practice
What should CS prescriptions have?
Be dated and signed on the actual date of writing
Full name and address
Drug name, strength, and dosage form
Quantity prescribed
Directions for use
Name, address, and DEA number of practitioner
Must be written in ink
Non-registered practitioners may use a DEA number
Can a provider sign multiple electronic scripts for patients?
Only if it’s at the same time for the same patient only.
They do not need to be sent right after signing
What must a physician have at a detox and maintenance clinic?
Physicians must be registered and may administer and dispense.
They can NOT prescribe. (only subuxone)
What can a non-registered physician do at a detox and maintenance clinic?
They can administer and dispense not more than a one day supply for no more than THREE days.
What can a institutional pharmacist dispense for a CII prescription?
A WRITTEN prescription and an ORDER
What is the quantity for an CII medication that was orally sent in?
limited quantity for the emergency period
How should oral prescriptions for CIIs be documented?
Must be immediately reduced to writing.
If unknown prescriber, pharmacist must ATTEMPT to verify identity.
Within 7 days, written form must be sent to the pharmacy, or DEA must be notified.
When is the faxing of CIIs acceptable?
Home infusion pharmacies for parenteral use
LTCF residents
Hospice enrolled patients.
The CII fax may count as the original prescription but until a real copy of it or the electronic copy is received, they cannot be dispensed.
What must be documented for a partial fill?
Date of EACH partial filling
Quantity dispensed
Remaining quantity to be dispensed
ID of the dispensing pharmacists
All partial fills must be completed within __ days for LTCF and hospice only
60 days
For ALL CIIs, partial fillings can be done for up to __ days from ___.
30 days from date prescription is written
What must be on a CII label?
1) Date of filling
2) Pharmacy name and address
3) Serial number of the prescription
4) Name of the patient
5) Name of the prescriber
6) Directions for use
7) Controlled substance warning
8) Other cautionary statements
What does the federal law NOT require on a drug label?
Name, strength, and quantity of the drug
When are CII label requirements not required for hospitals?
IF not for more than 7 days given
Ultimate user does not have possession
Pharmacist keeps adequate records to show supplier, product, and patient
What are acceptable prescription forms for CIII, CIV, and CV?
A written script from a practitioner.
A fax of a written script signed by the prescriber and transmitted from the prescriber’s office.
Oral script written down.
E-scripts
How many refills may CIIIs and CIVs have?
5 refills in six months
How many refills may CVs have?
Federal: have as many as written
State: five refills in six months
Can you add refills to a CIII-CV?
Yes, as long as it does NOT exceed 5 refills in 6 months
When do labeling requirements not apply for controls?
If the patient is institutionalized and not more than 34 day supply or 100 units.
Ultimate user does not possess the medication
Safeguards are in place and the pharmacist can find key info
When can you transfer a CII?
If it’s not filled and electronic
When can you not transfer a CII?
If it’s written, faxed, or oral
When can you transfer an unfilled CIII-CV?
Only refills may be transferred per federal law.
If a med has been partially filled at one pharmacy, it it not transferrable until that fill is completed.
If it’s been escribed -> transfer whole thing
When can a pharmacist dispense a CV without a prescription?
Purchaser is at least 18
Purchaser must be known to the pharmacist or provide ID
Sign a log book
Provide certain info to the pharmacist
What form must be used to destroy controlled substances?
form 41
What is required for a blanket authorization for the destruction of CSs?
Frequency
Method
Registrant’s past history
Security at registered location
Name of person responsible for destruction
When does federal law allow patients to return CSs to a pharmacy?
If the pharmacy is a hospital or retail pharmacy and the pharmacy must be registered as a collector with the DEA
What are the requirements for a collector pharmacy?
They may set up collection boxes at LTCFs
Collection boxes must have: an inner liner with a serial number, only accessible by employees of the collector, TWO employees must collect it, if in a pharmacy setting the collection box MUST be within sight of a pharmacy.
Only C2-C5s may be collected
What must a prescriber record for CSs?
What they dispense and what they order. They do not need to keep track of HOW MUCH they prescibe.
How often must inventory be done for CSs in pharmacies?
Federal: every 2 years
State: every year
How should you separate prescriptions of CSs?
CIIs separate from the others.
CIII-CV can be kept with non-controls if they are stamped with a letter s OR if you have a computer system that can separate them.
CIII-CV may be an estimate unless the bottle size is ___.
Greater than 1000 units
What form must be filled if a CS is lost or is stolen?
DEA form 106
What is filled out on a DEA form 106?
Name/address of business
DEA number
Date of theft
Local police notified
Type of theft
Markings on missing bottles
Controlled substances missing
What should you do with outdated controls?
Return to wholesaler or destroy (fill out form 41 first)
What does a DEA number consist of?
First letter: Provider (A,B,E,F)
M: Mid-level practitioner
P or R: Distributor
Second letter: last initial
What are the numbers on a DEA number?
1) Add the first, third, and fifth number
2) Add the second, fourth and sixth number then multiply by 2
3) Add the two numbers
They should equal the ninth digit
What is the limit on PSE?
No retail sales of more than 3.6 g per day and no retail sales of more than 9 g per 30 day periods.
Mail order limits are 7.5 g per 30 day
What is the procedure for the sale of PSE?
All products must be out of reach of customers.
Written or electronic logbook maintained for 5 years
Retailers must train employees prior to sales
What is required for a CS prescription?
Photo ID or known to the pharmacist
Is PSE reported to PMP?
No, because it’s a CV
What is the restriction for dextromethorphan?
Selling or purchasing DM for someone under 18
Unless it is a prescription.
Positive ID must be provided (DL, Military ID, state ID, passport)
How long are controlled substance prescriptions valid in louisiana?
90 days
If out of state, Non-louisiana licensed prescriber, __ day max for any CII or CIII opioid derivative
10 days
Unless PMP can be checked for issuing state or the rx is marked for cancer pain or terminally ill
Opioids may be partially filled for up to __ days
30 days from date written
Who can have naloxone?
Peace officer, EMS, or firefighter
Who can dispense naloxone?
Prescribers for a first responder or a pharmacist per RX or standing order (anyone that wishes to get naloxone)
How many hours of CE is required to renew CDs license?
3 hours
__ day limit on all OPIOID prescriptions for acute issues unless:
7 day limit
Unless treatment of chronic pain, treatment of cancer or palliative care, treatment of substance abuse or opioid dependence, or prescriber wants more than 7 days
